Chronic Hepatitis bPhase 1/2NCT06150014
A Clinical Study of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment Naive and Treated Patients With Chronic Hepatitis B
A Phase 1/2 study testing TQA3605 tablets, Entecavir dispersible tablets and Tenofovir disoproxil fumarate tablet in people with Chronic Hepatitis b, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 3 sites in China.
Trial summary
A randomized, double-blind Phase Ib/IIa multicenter trial design was used. All eligible subjects received TQA3605 tablets/placebo plus nucleoside (acid) analogues. A total of 88 subjects were required Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- TQA3605 tablets, Entecavir dispersible tablets and Tenofovir disoproxil fumarate tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 3 sitesChina
- Study dates
- 7 Dec 2023to Sep 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate in this study and sign informed consent;
- Male and female, ≥18 years old and ≤70 years old (subject to the date of signing the informed consent);
- Patients diagnosed with chronic hepatitis B (CHB) who have been serum HBsAg positive for more than 6 months and HBeAg positive or negative ;
- The liver fibrosis ultrasound transient imaging elastic technology (Fibroscan/FibroTouch) showed that the liver hardness (LSM) was less than 12.4 Kpa;
- Patients with chronic hepatitis B after treatment;
- Treatment-naïve patients of chronic hepatitis B patients;
Who cannot join
- Complicated with other infected disease such as hepatitis A virus (HAV), hepatitis C virus (HCV), Hepatitis D virus (HDV), hepatitis E virus (HEV), human immunodeficiency virus (HIV), syphilis (syphilis antibody positive and need treatment determined by the investigator);
- Abdominal ultrasound or other imaging or histology showed suspected cirrhosis or other liver disease before or during screening;
- Patients have a history of hepatocellular carcinoma (HCC) before or at the time of screening, or may be at risk for HCC;
- Active autoimmune disease diagnosed with immunodeficiency or undergoing systemic therapy which was continuing within 2 weeks before first dosing;
- Currently being treated with nephrotoxic drugs or drugs that alter renal excretion;
- Abnormal thyroid function;
Show all 20Show fewer
- Renal diseases such as chronic kidney disease and renal insufficiency or creatinine clearance (CLCr) <60 ml/min during the screening period;
- Hematologic and biochemical abnormalities;
- History of allergy to the investigational drug or its excipients;
- Recipients of solid organs or bone marrow transplants;
- A history of malignant tumors within the past 5 years;
- Interstitial lung disease, acute lung disease, etc.;
- Uncontrolled systemic diseases such as high blood pressure and diabetes;
- Have used any investigational drug or participated in a clinical trial within one month prior to the administration of study drug;
- Those who received live attenuated vaccine within 28 days before the start of study treatment, inactivated vaccine within 7 days, or planned vaccination during the study period;
- The investigator determines that there is any medical or psychiatric condition that puts the subject at risk, interferes with participation in the study, or interferes with the interpretation of the study results;
- Female subjects that were pregnant, lactating or had a positive pregnancy result during the screening period or during the trial; Male and female patients with reproductive potential who were unwilling to use effective contraceptive methods during the study period;
- Subjects who have any medical condition that may affect the absorption of oral drugs;
- Within 12 weeks prior to screening, treated chronic hepatitis B patients who had stopped taking nucleoside (acid) analogues for more than 14 consecutive days;
- Those considered unsuitable for enrollment by the investigators.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
Chongqing, Chongqing Municipality, 400038
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shannxi, 710061
About this study
Official title: Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment-naïve Patients and Treated Patients With Chronic Hepatitis B
A randomized, double-blind Phase Ib/IIa multicenter trial design was used. All eligible subjects received TQA3605 tablets/placebo plus nucleoside (acid) analogues. A total of 88 subjects were required
- Conditions
- Chronic Hepatitis b
- Being tested
- Placebo, TQA3605 tablets, Entecavir dispersible tablets, Tenofovir disoproxil fumarate tablet, Tenofovir alafenamide fumarate tablet
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
TQA3605 placebo tablets were orally administered on an empty stomach (at least 2 hours before or after meals) with warm.
TQA3605 tabletsDrug
TQA3605 inhibits viral replication.
Entecavir dispersible tabletsDrug
Entecavir inhibits viral replication and indicated for chronic hepatitis B treatment.
Tenofovir disoproxil fumarate tabletDrug
Tenofovir disoproxil fumarate is a Nucleotide reverse transcriptase inhibitor.
Tenofovir alafenamide fumarate tabletDrug
Tenofovir alafenamide fumarate inhibits hepatitis B virus replication.
| Study group | Role | What they receive |
|---|---|---|
| Placebo +Nucleoside (acid) analogs (NAs) combination therapy 24 weeks | Placebo comparator | Placebo and Nucleoside (acid) analogues, taken orally once daily, continue for 24 weeks. Receives: Drug: Placebo; Drug: Entecavir dispersible tablets; Drug: Tenofovir disoproxil fumarate tablet; Drug: Tenofovir alafenamide fumarate tablet |
| 50 mg of TQA3605 tablets +NAs combination therapy 24 weeks | Active comparator | 50 mg of TQA3605 tablets and Nucleoside (acid) analogues, taken orally once daily, continue for 24 weeks. Receives: Drug: TQA3605 tablets; Drug: Entecavir dispersible tablets; Drug: Tenofovir disoproxil fumarate tablet; Drug: Tenofovir alafenamide fumarate tablet |
| 100 mg of TQA3605 tablets +NAs combination therapy 48 weeks | Active comparator | TQA3605 is taken orally 100mg once daily; Nucleoside (acid) analogues were used once daily for 48 weeks. Receives: Drug: TQA3605 tablets; Drug: Entecavir dispersible tablets; Drug: Tenofovir disoproxil fumarate tablet; Drug: Tenofovir alafenamide fumarate tablet |
| 200 mg of TQA3605 tablets +NAs combination therapy 48 weeks | Active comparator | TQA3605 is taken orally 200mg once daily; Nucleoside (acid) analogues were used once daily for 48 weeks. Receives: Drug: TQA3605 tablets; Drug: Entecavir dispersible tablets; Drug: Tenofovir disoproxil fumarate tablet; Drug: Tenofovir alafenamide fumarate tablet |
| Placebo +Nucleoside (acid) analogs (NAs) combination therapy | Placebo comparator | Placebo taken orally once daily, continue for 12 weeks. Placebo was then combined with nucleoside (acid) analogues (once daily) for 36 weeks Receives: Drug: Placebo; Drug: Entecavir dispersible tablets; Drug: Tenofovir disoproxil fumarate tablet; Drug: Tenofovir alafenamide fumarate tablet |
| 100 mg of TQA3605 tablets +NAs combination therapy | Active comparator | TQA3605 was taken orally 100mg once a day for 12 weeks. It was then combined with nucleoside (acid) analogues (once daily) for 36 weeks. Receives: Drug: TQA3605 tablets; Drug: Entecavir dispersible tablets; Drug: Tenofovir disoproxil fumarate tablet; Drug: Tenofovir alafenamide fumarate tablet |
| 200 mg of TQA3605 tablets +NAs combination therapy | Active comparator | TQA3605 was taken orally 200mg once a day for 12 weeks. It was then combined with nucleoside (acid) analogues (once daily) for 36 weeks. Receives: Drug: TQA3605 tablets; Drug: Entecavir dispersible tablets; Drug: Tenofovir disoproxil fumarate tablet; Drug: Tenofovir alafenamide fumarate tablet |
| 300 mg of TQA3605 tablets+NAs combination therapy | Active comparator | TQA3605 was taken orally 300mg once a day for 12 weeks. It was then combined with nucleoside (acid) analogues (once daily) for 36 weeks. Receives: Drug: TQA3605 tablets; Drug: Entecavir dispersible tablets; Drug: Tenofovir disoproxil fumarate tablet; Drug: Tenofovir alafenamide fumarate tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events (AEs)
The incidence of adverse events (AEs) during treatment
Measured: Up to 48 weeks
Severity of adverse events (AEs)
The severity of adverse events (AEs) during treatment
Measured: Up to 48 weeks
Incidence of serious adverse events (SAEs)
The incidence of serious adverse events (SAEs) during treatment
Measured: Up to 48 weeks
Severity of serious adverse events (SAEs)
The severity of serious adverse events (SAEs) during treatment
Measured: Up to 48 weeks
Secondary outcomes (17)
Incidence of abnormal laboratory test values
The incidence of abnormal laboratory values during treatment, e.g. triglycerides.
Measured: Up to 48 weeks
Severity of abnormal laboratory test values
The severity of abnormal laboratory values during treatment, e.g. triglycerides.
Measured: Up to 48 weeks
Deoxyribonucleic acid level of hepatitis B virus
Changes in hepatitis B virus deoxyribonucleic acid (HBV DNA) levels from baseline
Measured: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study
Hepatitis B surface antigen
Changes in serum hepatitis B surface antigen (HBsAg) from baseline
Measured: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study
Hepatitis B e antigen
Changes in serum hepatitis B e antigen (HBeAg) from baseline
Measured: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study
Serologic clearance and/or serologic conversion of HBsAg
Proportion of subjects with HBsAg serologic clearance and/or serologic conversion
Measured: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study
Serologic clearance and/or serologic conversion of HBeAg
Proportion of subjects with HBeAg serologic clearance and/or serologic conversion
Measured: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study
Virological breakthrough rate
The proportion of subjects who achieved a virological breakthrough (defined as a confirmed increase of HBV DNA levels >1.0 log10 IU/ml from the minimum during treatment).
Measured: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study
Peak time (Tmax)
Time to reach peak blood concentration after a single dose
Measured: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Peak concentration
The highest plasma drug concentration that can be achieved after medication
Measured: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Area under blood concentration-time curve (AUC)
The amount of drug absorbed into the human circulation after a single dose can be estimated using the area under the blood concentration-time curve
Measured: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Apparent volume of distribution (Vd/F)
When a drug reaches homeostasis in the body, the ratio of the amount of drug in the body to the blood concentration is called the apparent volume of distribution.
Measured: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Plasma clearance
The amount of plasma that the kidneys completely clear in unit time (per minute).
Measured: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Elimination half-life
The time it takes for the plasma concentration to drop by half.
Measured: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Steady state peak time
The time required to reach peak steady-state concentration after administration
Measured: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Steady state maximum concentration
The highest blood concentration that occurs after stabilization
Measured: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Steady state minimal concentration
The lowest blood concentration that occurs after stabilization
Measured: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start7 Dec 2023
- Primary completionDec 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150014
- Sponsor's protocol ID
- TQA3605-Ib/IIa-01
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment-naïve Patients and Treated Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT06150014
- Acronym / sponsor ID
- TQA3605-Ib/IIa-01
- Conditions
- Chronic Hepatitis b
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind Phase Ib/IIa multicenter trial design was used. All eligible subjects received TQA3605 tablets/placebo plus nucleoside (acid) analogues. A total of 88 subjects were required
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Placebo +Nucleoside (acid) analogs (NAs) combination therapy 24 weeks | Placebo comparator | Drug: Placebo, Drug: Entecavir dispersible tablets, Drug: Tenofovir disoproxil fumarate tablet, Drug: Tenofovir alafenamide fumarate tabletPlacebo and Nucleoside (acid) analogues, taken orally once daily, continue for 24 weeks. |
| 50 mg of TQA3605 tablets +NAs combination therapy 24 weeks | Active comparator | Drug: TQA3605 tablets, Drug: Entecavir dispersible tablets, Drug: Tenofovir disoproxil fumarate tablet, Drug: Tenofovir alafenamide fumarate tablet50 mg of TQA3605 tablets and Nucleoside (acid) analogues, taken orally once daily, continue for 24 weeks. |
| 100 mg of TQA3605 tablets +NAs combination therapy 48 weeks | Active comparator | Drug: TQA3605 tablets, Drug: Entecavir dispersible tablets, Drug: Tenofovir disoproxil fumarate tablet, Drug: Tenofovir alafenamide fumarate tabletTQA3605 is taken orally 100mg once daily; Nucleoside (acid) analogues were used once daily for 48 weeks. |
| 200 mg of TQA3605 tablets +NAs combination therapy 48 weeks | Active comparator | Drug: TQA3605 tablets, Drug: Entecavir dispersible tablets, Drug: Tenofovir disoproxil fumarate tablet, Drug: Tenofovir alafenamide fumarate tabletTQA3605 is taken orally 200mg once daily; Nucleoside (acid) analogues were used once daily for 48 weeks. |
| Placebo +Nucleoside (acid) analogs (NAs) combination therapy | Placebo comparator | Drug: Placebo, Drug: Entecavir dispersible tablets, Drug: Tenofovir disoproxil fumarate tablet, Drug: Tenofovir alafenamide fumarate tabletPlacebo taken orally once daily, continue for 12 weeks. Placebo was then combined with nucleoside (acid) analogues (once daily) for 36 weeks |
| 100 mg of TQA3605 tablets +NAs combination therapy | Active comparator | Drug: TQA3605 tablets, Drug: Entecavir dispersible tablets, Drug: Tenofovir disoproxil fumarate tablet, Drug: Tenofovir alafenamide fumarate tabletTQA3605 was taken orally 100mg once a day for 12 weeks. It was then combined with nucleoside (acid) analogues (once daily) for 36 weeks. |
| 200 mg of TQA3605 tablets +NAs combination therapy | Active comparator | Drug: TQA3605 tablets, Drug: Entecavir dispersible tablets, Drug: Tenofovir disoproxil fumarate tablet, Drug: Tenofovir alafenamide fumarate tabletTQA3605 was taken orally 200mg once a day for 12 weeks. It was then combined with nucleoside (acid) analogues (once daily) for 36 weeks. |
| 300 mg of TQA3605 tablets+NAs combination therapy | Active comparator | Drug: TQA3605 tablets, Drug: Entecavir dispersible tablets, Drug: Tenofovir disoproxil fumarate tablet, Drug: Tenofovir alafenamide fumarate tabletTQA3605 was taken orally 300mg once a day for 12 weeks. It was then combined with nucleoside (acid) analogues (once daily) for 36 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects voluntarily participate in this study and sign informed consent;
- Male and female, ≥18 years old and ≤70 years old (subject to the date of signing the informed consent);
- Patients diagnosed with chronic hepatitis B (CHB) who have been serum HBsAg positive for more than 6 months and HBeAg positive or negative ;
- The liver fibrosis ultrasound transient imaging elastic technology (Fibroscan/FibroTouch) showed that the liver hardness (LSM) was less than 12.4 Kpa;
- Patients with chronic hepatitis B after treatment;
Key exclusion criteria (20 listed)
- Complicated with other infected disease such as hepatitis A virus (HAV), hepatitis C virus (HCV), Hepatitis D virus (HDV), hepatitis E virus (HEV), human immunodeficiency virus (HIV), syphilis (syphilis antibody positive and need treatment determined by the investigator);
- Abdominal ultrasound or other imaging or histology showed suspected cirrhosis or other liver disease before or during screening;
- Patients have a history of hepatocellular carcinoma (HCC) before or at the time of screening, or may be at risk for HCC;
- Active autoimmune disease diagnosed with immunodeficiency or undergoing systemic therapy which was continuing within 2 weeks before first dosing;
- Currently being treated with nephrotoxic drugs or drugs that alter renal excretion;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboTQA3605 placebo tablets were orally administered on an empty stomach (at least 2 hours before or after meals) with warm. | Drug | Placebo +Nucleoside (acid) analogs (NAs) combination therapy, Placebo +Nucleoside (acid) analogs (NAs) combination therapy 24 weeks |
| TQA3605 tabletsTQA3605 inhibits viral replication. | Drug | 100 mg of TQA3605 tablets +NAs combination therapy, 100 mg of TQA3605 tablets +NAs combination therapy 48 weeks, 200 mg of TQA3605 tablets +NAs combination therapy, 200 mg of TQA3605 tablets +NAs combination therapy 48 weeks, 300 mg of TQA3605 tablets+NAs combination therapy, 50 mg of TQA3605 tablets +NAs combination therapy 24 weeks |
| Entecavir dispersible tabletsEntecavir inhibits viral replication and indicated for chronic hepatitis B treatment. | Drug | 100 mg of TQA3605 tablets +NAs combination therapy, 100 mg of TQA3605 tablets +NAs combination therapy 48 weeks, 200 mg of TQA3605 tablets +NAs combination therapy, 200 mg of TQA3605 tablets +NAs combination therapy 48 weeks, 300 mg of TQA3605 tablets+NAs combination therapy, 50 mg of TQA3605 tablets +NAs combination therapy 24 weeks, Placebo +Nucleoside (acid) analogs (NAs) combination therapy, Placebo +Nucleoside (acid) analogs (NAs) combination therapy 24 weeks |
| Tenofovir disoproxil fumarate tabletTenofovir disoproxil fumarate is a Nucleotide reverse transcriptase inhibitor. | Drug | 100 mg of TQA3605 tablets +NAs combination therapy, 100 mg of TQA3605 tablets +NAs combination therapy 48 weeks, 200 mg of TQA3605 tablets +NAs combination therapy, 200 mg of TQA3605 tablets +NAs combination therapy 48 weeks, 300 mg of TQA3605 tablets+NAs combination therapy, 50 mg of TQA3605 tablets +NAs combination therapy 24 weeks, Placebo +Nucleoside (acid) analogs (NAs) combination therapy, Placebo +Nucleoside (acid) analogs (NAs) combination therapy 24 weeks |
| Tenofovir alafenamide fumarate tabletTenofovir alafenamide fumarate inhibits hepatitis B virus replication. | Drug | 100 mg of TQA3605 tablets +NAs combination therapy, 100 mg of TQA3605 tablets +NAs combination therapy 48 weeks, 200 mg of TQA3605 tablets +NAs combination therapy, 200 mg of TQA3605 tablets +NAs combination therapy 48 weeks, 300 mg of TQA3605 tablets+NAs combination therapy, 50 mg of TQA3605 tablets +NAs combination therapy 24 weeks, Placebo +Nucleoside (acid) analogs (NAs) combination therapy, Placebo +Nucleoside (acid) analogs (NAs) combination therapy 24 weeks |
Primary outcome
The incidence of adverse events (AEs)
Time frame: Up to 48 weeks
The incidence of adverse events (AEs) during treatment
Severity of adverse events (AEs)
Time frame: Up to 48 weeks
The severity of adverse events (AEs) during treatment
Incidence of serious adverse events (SAEs)
Time frame: Up to 48 weeks
The incidence of serious adverse events (SAEs) during treatment
Severity of serious adverse events (SAEs)
Time frame: Up to 48 weeks
The severity of serious adverse events (SAEs) during treatment
17 secondary outcomes
Incidence of abnormal laboratory test values
Time frame: Up to 48 weeks
Severity of abnormal laboratory test values
Time frame: Up to 48 weeks
Deoxyribonucleic acid level of hepatitis B virus
Time frame: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study
Hepatitis B surface antigen
Time frame: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study
Hepatitis B e antigen
Time frame: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study
Serologic clearance and/or serologic conversion of HBsAg
Time frame: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study
Serologic clearance and/or serologic conversion of HBeAg
Time frame: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study
Virological breakthrough rate
Time frame: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study
Peak time (Tmax)
Time frame: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Peak concentration
Time frame: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Area under blood concentration-time curve (AUC)
Time frame: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Apparent volume of distribution (Vd/F)
Time frame: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Plasma clearance
Time frame: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Elimination half-life
Time frame: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Steady state peak time
Time frame: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Steady state maximum concentration
Time frame: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Steady state minimal concentration
Time frame: pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
Related trials for Chronic Hepatitis b
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TQA3605 tablets, Entecavir dispersible tablets and Tenofovir disoproxil fumarate tablet in people with Chronic Hepatitis b, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse events (AEs) (time frame: Up to 48 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.